drugset / Trial / NCT01051700

A Safety Study in Healthy Volunteers to Evaluate Safety, How Fast the Drug is Absorbed, and the Side Effects of the Drug in Humans

NCT01051700

Phase 1 Completed 72 enrolled GlaxoSmithKline
RandomizedParallel-groupSingle-blindSupportive care

Summary

This study is to evaluate the safety, absorption rate and side effects associated with the study drug. Healthy volunteers will be given a single dose of the drug in Part 1. Subjects will be dosed at the same time at several different sites. In Part 2 of the study elderly volunteers will participate in a 14 day repeat dose session receiving either study drug or a placebo (sugar pill). Data from at least 7 days of safety will be reviewed from the first set of volunteers before increasing the doses for the next set. All results will be used for planning the next study.

Timeline

Start
2010-01-12
Primary completion
2010-05-27
Completion
2010-05-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pazopanib Small molecule 5 mg Oral
Subject Pazopanib Small molecule 10 mg Oral
Subject Pazopanib Small molecule 20 mg Oral

Indications